NCT02808299Unknown不适用
Liver Injury by Statins in Coronary Heart Disease (CHD) Patients With History of Hepatitis B Virus (HBV) Infection
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2016年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- changes of alanine transaminase (ALT, U/L)
研究概览
简要总结
The purpose of this study is to investigate the incidence of liver injury by statins in coronary heart disease (CHD) patients with history of hepatitis B virus (HBV) infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with CHD receive long-term statin treatment
排除标准
- •ALT is over ULN at baseline
- •infection of Hepatitis A Virus, Hepatitis C Virus or Hepatitis E Virus
- •triglyceride is over 4.5 mmol/L
- •decompensated liver cirrhosis (Child B or C)
- •active stage of HBV
- •infection of Burkitt's lymphoma virus or cytomegalovirus, or other acute infectious disease
- •congestive heart failure
- •malignant tumor
- •autoimmune disease
- •receive other potential hepatotoxicity drugs such as immunosuppressant, antituberculotic and non-steroid anti-inflammatory drug.
结局指标
主要结局
changes of alanine transaminase (ALT, U/L)
时间窗: one month, three months, six months
The peak increases of ALT from baseline to follow-up
number of participants with alanine transaminase (ALT) increasing over 3 folds of upper limit normally (ULN)
时间窗: one month, three months, six months
次要结局
- number of participants with alanine transaminase (ALT) increasing over the ULN(one month, three months, six months)
研究者
研究点 (1)
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